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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201219

Biocore9 Femoral Head Resurfacing Component · Biocore9, LLC · decided 2021-01-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 39.5 mmBiocore9, LLCKXA00810068850383
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 41 mmBiocore9, LLCKXA00810068850390
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 51 mmBiocore9, LLCKXA00810068850451
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 52.5 mmBiocore9, LLCKXA00810068850468
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 44 mmBiocore9, LLCKXA00810068850413
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 42.5 mmBiocore9, LLCKXA00810068850406
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 45.5 mmBiocore9, LLCKXA00810068850420
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 47 mmBiocore9, LLCKXA00810068850437
Biocore9 Femoral Resurfacing ComponentFemoral Resurfacing Component - 49 mmBiocore9, LLCKXA00810068850444